Singapore HSA registration DE0009217
Respironics Trilogy 100 System
Singapore·CLASS C·Respironics, Inc.·Registered May 30, 2012Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Anaesthesiology
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90192000
Registration information
- Registration Number
- DE0009217
- Registration Date
- May 30, 2012
- Change Notification Approval Date
- August 31, 2021
- Retention Due Date
- May 29, 2025
Product description
is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Product Owner
- Short Name
- Respironics, Inc.
- Address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
- Address
- 622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
- Address
- 25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 VENTURE DRIVE, VISION EXCHANGE, #22-28, SINGAPORE 608526
Model information
- Model Name(s)
- Oximetry accessory, Intl DirectView Software Package OxiCheck with grey t-piece Masimo Standard Multisite Wrap Masimo Cleanshield Multisite Wrap Trilogy O2 Quick-Disconnect Insert, 2-Pack Alice PDX serial cable DirectView SD Card Mailer (10 pack) Adapter 22mm X 22mm Adapter 22mm X 15mm Trilogy Nurse Call Adaptor Cable Trilogy Remote Alarm Adaptor Cable Inlet Airpath Assembly Trilogy Isolated RS232 Serial Cable (Alice Cable) Trilogy Expternal Battery Cable SD Card Reader Trilogy Small Products Roll Stand Trilogy Active w/PAP exhalation circuit, Adult Trilogy Active w/PAP exhalation circuit, Ped Trilogy Passive exhalation circuit, Adult Trilogy Passive exhalation circuit, Ped Trilogy 100 DirectView Software Package (Online download only) Auto-DC Cable Adult Invasive Pass Disp NonHtd Circ 10pk Adult Invasive Pass Disp NonHtd Circ 20pk Padiatric Invasive PassDisp NonHtd Circ 10pk Padiatric Invasive PassDisp NonHtd Circ 20pk Adult Non-Invasive Pass Disp NonHtd Circ 10pk Adult Non-Invasive Pass Disp NonHtd Circ 20pk Nurse Call 1/4" to 2.5mm NC - 600 Nurse Call 1/4" to 2.5mm NO - 600 Accessory carrying case RP-Mount Plate, Trilogy Roll-Stand RP-Screw, MNT Plate, PKG/4, Trilogy R-Stand High Performance/low power oximetry module Oximetry interface cable for Trilogy LNCS DCIP Pediatric reusable sensor LNCS DBI Adult soft reusable sensor LNCS Adtx Adult disposable sensor LNCS Pdtx Pediatric disposable sensor LNCS Inf Infant disposable sensor LNCS DCI Adult reusable sensor LNCS YI Multisite reusable sensor Masimo extension cable for LNCS sensor connector Criterion 40 pressure monitor Criterion 60 pressure & oxygen monitor Filter, Bacteria, 22mm, Single Use Filter, Bacteria, 22mm, Single Use, 50 per pack
- Model Identifier(s)
- 100215E 1005297 1016861 1019531 1019532 1040390 1040805 1041151 1044186 1044191 1045290 1045291 1045587 1046972 1047295 1047300 1047410 1052064 1052065 1052066 1052127 1054096 1055635 1067424 1069443 1069444 1069445 1069446 1069467 1069468 1069979 1069980 1070185 1074004 1074137 1075383 1080964 1081515 1081516 1081517 1081518 1081519 1081984 1081985 1082474 8-100210-00 8-100351-00 C06417 C06418
About this record
Access comprehensive regulatory information for Respironics Trilogy 100 System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009217 and owned by Respironics, Inc.. The device was registered on May 30, 2012.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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